Key result
Acute treatment of ruptured intracranial aneurysms with PED-Shield and single antiplatelet therapy achieved complete or near-complete occlusion in 85.7% of patients at median day 7.
Why the study?
The Pipeline Embolisation Device with Shield technology (PED-Shield) has reduced thrombogenicity, which may allow safe acute treatment of aneurysmal subarachnoid haemorrhage with single antiplatelet therapy.
Does PED-Shield with single antiplatelet therapy provide safe and effective treatment for acute aneurysmal subarachnoid haemorrhage?
Observational (n=14)
Yes
Does PED-Shield with single antiplatelet therapy provide safe and effective treatment for acute aneurysmal subarachnoid haemorrhage?
The off-label use of PED-Shield with single antiplatelet therapy appears feasible and potentially safe for the acute treatment of ruptured intracranial aneurysms, though postoperative heparin infusion may increase complication risks.
Answers are grounded in this paper and cite their sources.
May support PED-Shield with single antiplatelet therapy in select acute SAH cases; hypothesis-generating and requires randomized confirmation.
BACKGROUND: The Pipeline Embolisation Device with Shield technology (PED-Shield) is suggested to have reduced thrombogenicity. This reduced thrombogenicity may make it possible to use safely in the acute treatment of aneurysmal subarachnoid haemorrhage (aSAH) on single antiplatelet therapy (SAPT). OBJECTIVE: To evaluate the safety and efficacy of the off-label use of PED-Shield with SAPT for the acute treatment of aSAH. METHODS: Patients who underwent acute treatment of ruptured intracranial aneurysms with the PED-Shield with SAPT were retrospectively identified from prospectively maintained databases at three Australian neurointerventional centres. Patient demographics, aneurysm characteristics, clinical and imaging outcomes were reviewed. RESULTS: Fourteen patients were identified (12 women), median age 64 (IQR 21.5) years. Aneurysm morphology was saccular in seven, fusiform in five, and blister in two. Aneurysms arose from the anterior circulation in eight patients (57.1%). Six (42.9%) patients were poor grade (World Federation of Neurological Societies grade ≥IV) SAH. Median time to treatment was 1 (IQR 0.5) day. Complete or near complete aneurysm occlusion (Raymond-Roy <3) was achieved in 12 (85.7%) patients at the end of early-acute follow-up (median day 7 after SAH). Permanent, treatment-related morbidity occurred in one (7.1%) patient and one (7.1%) treatment-related death occurred. The use of a postoperative heparin infusion (n=5) was associated with a higher rate of all complications (80.0% vs 11.1%, p=0.023) and symptomatic complications (60% vs 0.0%, p=0.028). No symptomatic ischaemic or haemorrhagic complications were observed in the patients who did not receive a post-operative heparin infusion. Nine (64.3%) patients were functionally independent on discharge from the treatment centre. CONCLUSION: The PED-Shield may be safe to use in the acute treatment of ruptured intracranial aneurysms with SAPT. Further investigation with a formal treatment registry is needed.
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Manning et al. (2018) conducted an observational in Aneurysmal subarachnoid haemorrhage (aSAH) (n=14). Pipeline Embolisation Device with Shield technology (PED-Shield) with single antiplatelet therapy (SAPT) was evaluated on Complete or near complete aneurysm occlusion (Raymond-Roy <3). Acute treatment of ruptured intracranial aneurysms with PED-Shield and single antiplatelet therapy achieved complete or near-complete occlusion in 85.7% of patients at median day 7.
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